DRUG DESCRIPTION

ZOLINZA contains vorinostat, which is described chemically as N-hydroxy-N'-phenyloctanediamide.
The empirical formula is C14H20N2O3.
The molecular weight is 264.32 and the structural formula is:

Vorinostat is a white to light orange powder. It is very slightly soluble in
water, slightly soluble in ethanol, isopropanol and acetone, freely soluble
in dimethyl sulfoxide and insoluble in methylene chloride. It has no chiral
centers and is non-hygroscopic. The differential scanning calorimetry ranged
from 161.7 (endotherm) to 163.9°C. The pH of saturated water solutions of
vorinostat drug substance was 6.6. The pKa of vorinostat was determined to be
9.2.

What are the precautions when taking vorinostat (Zolinza)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This drug may cause dizziness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for...

Read All Potential Precautions of Zolinza »

Zolinza Consumer (continued)

SIDE EFFECTS: Tiredness, loss of appetite, dizziness, dry mouth, change in the sense of taste, hair loss, headache, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Nausea, vomiting, and diarrhea can also occur and may be severe. Tell your doctor right away if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve them. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Tell your doctor right away if you have any unlikely but serious side effects, including: pain/redness/swelling of arms or legs, easy bruising/bleeding, unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat).

Get medical help right away if any of these rare but serious side effects occur: chest pain, trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Continue taking vorinostat and talk with your doctor if you have any of these less serious side effects:

nausea, vomiting, diarrhea, constipation;

headache, tired feeling;

loss of appetite;

dry mouth, changes in the way things taste;

weight loss;

chills;

hair loss; or

muscle spasms.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about vorinostat (Zolinza)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Drink at least 2 liters of water each day to keep from getting dehydrated while you are taking vorinostat. Tell your doctor if you have severe vomiting or diarrhea during treatment.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not crush or open a vorinostat capsule. Swallow the pill whole. The medicine inside the capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If contact occurs, wash the skin area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken capsule, ask your doctor or pharmacist how to safely dispose of it.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.